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FAQs for RFA MH-15-850 Gut-Microbiome-Brain Interactions and Mental Health

Q: The RFA says that “Applications proposing studies with human subjects are not responsive to the FOA and will not be reviewed.” Will my application be deemed non-responsive if some of my experiments would use samples from a clinical (patient) database, e.g. using a humanized microbiota rodent model?

A: No. Studies that employ human clinical samples in non-human animals to identify mechanisms by which the microbiome modifies brain circuits that subserve mental health-relevant behaviors are within the scope of this RFA. We encourage you to contact one of the Scientific/Research Contacts listed in Section VII. Agency Contacts of the RFA with any questions about the responsiveness of your planned application.

Q: The RFA says that “Applications proposing studies with human subjects are not responsive to the FOA and will not be reviewed.” Will my application be deemed non-responsive if only some of my proposed experiments involve human subjects?

A: Yes. An application is non-responsive if any of the proposed experiments involve experiments on human subjects. An application is non-responsive if it includes studies analyzing existing human data sets.

Q: This FOA encourages mechanistic studies. What does this statement mean?

A: The intent of this FOA is to stimulate exploratory studies followed by hypothesis-driven studies that investigate mechanisms by which the gut microbiota influences the development, organization, structure and function of brain circuits related to cognitive function, emotion regulation and social-cognitive processing. NIMH encourages experimental designs that move beyond correlational analyses (e.g. whether changes in gut microbiota correlate with changes in brain and relevant behavioral outcomes) to test causal hypotheses. Studies that causally test the involvement of a specific route by which the microbiome may affect the brain (e.g., via the vagus nerve, directly crossing the blood-brain barrier, immune, endocrine and/or novel signaling pathways) are strongly encouraged. We encourage you to contact one of the Scientific/Research Contacts listed in Section VII. Agency Contacts of the RFA with any questions about the responsiveness of your planned application.

Q: What are the implications of NOT-MH-15-001 for my planned application?

A: If you downloaded the application forms package from RFA-MH-15-850 before October 1, 2014, you have the wrong budget forms for this grant program. You should revisit RFA-MH-15-850 and download the new (correct) forms package and use this forms package for application preparation and submission.